American Dental Association

FDA Takes Enforcement Action Against Unapproved Pediatric Fluoride Supplements Citing Gut Microbiome Concerns

- The FDA issued enforcement notices to four companies marketing unapproved ingestible fluoride prescription drugs for children, citing concerns about systemic safety and potential gut microbiome alterations. - A systematic review of 49 studies found that systemic fluoride exposure can shift gut microbial composition, with higher concentrations potentially increasing unhealthy microbe ratios. - The agency's action stems from President Trump's "Make Our Children Healthy Again" initiative and follows a comprehensive safety review showing these products have never undergone FDA approval despite decades of use. - FDA Commissioner Marty Makary emphasized that fluoride may kill beneficial intestinal bacteria important for children's health, similar to how it kills bacteria on teeth.